2024
Devimistat (CPI-613) With Modified Fluorouarcil, Oxaliplatin, Irinotecan, and Leucovorin (FFX) Versus FFX for Patients With Metastatic Adenocarcinoma of the Pancreas: The Phase III AVENGER 500 Study
Philip P, Sahai V, Bahary N, Mahipal A, Kasi A, Lima C, Alistar A, Oberstein P, Golan T, Metges J, Lacy J, Fountzilas C, Lopez C, Ducreux M, Hammel P, Salem M, Bajor D, Benson A, Luther S, Pardee T, Van Cutsem E. Devimistat (CPI-613) With Modified Fluorouarcil, Oxaliplatin, Irinotecan, and Leucovorin (FFX) Versus FFX for Patients With Metastatic Adenocarcinoma of the Pancreas: The Phase III AVENGER 500 Study. Journal Of Clinical Oncology 2024, 42: 3692-3701. PMID: 39088774, DOI: 10.1200/jco.23.02659.Peer-Reviewed Original ResearchMetastatic pancreatic adenocarcinomaOverall survivalCPI-613Randomized phase III trialTreatment-emergent adverse eventsExperimental armDifficult-to-treat diseaseFavorable performance statusProgression-free survivalTreatment naive patientsFirst-line therapyPhase I studyPhase III trialsMedian OSMetastatic adenocarcinomaIII trialsFirst-linePerformance statusPancreatic adenocarcinomaAdverse eventsDevimistatDay 1Disease progressionControl armPatients
2018
A phase IB/II randomized study of mFOLFIRINOX (mFFOX) + pegylated recombinant human hyaluronidase (PEGPH20) versus mFFOX alone in patients with good performance status metastatic pancreatic adenocarcinoma (mPC): SWOG S1313 (NCT #01959139).
Ramanathan R, McDonough S, Philip P, Hingorani S, Lacy J, Kortmansky J, Thumar J, Chiorean E, Shields A, Behl D, Mehan P, Gaur R, Seery T, Guthrie K, Hochster H. A phase IB/II randomized study of mFOLFIRINOX (mFFOX) + pegylated recombinant human hyaluronidase (PEGPH20) versus mFFOX alone in patients with good performance status metastatic pancreatic adenocarcinoma (mPC): SWOG S1313 (NCT #01959139). Journal Of Clinical Oncology 2018, 36: 208-208. DOI: 10.1200/jco.2018.36.4_suppl.208.Peer-Reviewed Original ResearchMetastatic pancreatic adenocarcinomaPhase II studyOverall survivalII studyPhase Ib/IIProphylactic growth factor supportUntreated metastatic pancreatic adenocarcinomaRandomized phase II studyGemcitabine/nab-paclitaxelAdequate organ functionMedian overall survivalGrowth factor supportInterim futility analysisRecombinant human hyaluronidaseClinical trial informationDelivery of gemcitabineBolus 5FULMWH prophylaxisMedian OSTumor hyaluronanCombination armNab-paclitaxelPrimary endpointThromboembolic eventsStandard arm